Pipeline

A unique understanding of time-dependent biological processes informs everything we innovate for the treatment of chronic neurologic disorders. We continue to search for time-dependent patterns in diseases to reshape medicines and drive improved clinical outcomes for people in need.

Our medicines are timed for the benefit of patients.

ADS-5102 (amantadine) extended-release capsules

Multiple Sclerosis: Walking Impairment

Multiple sclerosis (MS) is a chronic autoimmune-mediated disorder that affects approximately 400,000 people in the United States.1 Walking impairment is a central feature of MS progression.2,3,4 The reported prevalence of impaired mobility due to MS ranges from 50% to over 90% of patients.1 As also reported in Parkinson’s disease, dysregulation of the NMDA receptor has been associated with the symptomology of MS,5 therefore symptoms may be improved by modulating overactivated NMDA receptor signaling. In addition, the impact of walking impairment and related symptoms (eg, fatigue, depression, and cognition) is most profound during the daytime when MS patients are engaged in activities of daily living.6,7 As a result, an effective treatment should provide relief beginning in the morning, and be sustained throughout the day, while not disrupting sleep.

ADS-5102, a high-dose amantadine investigational agent taken once-daily at bedtime, was designed to provide a slow initial rate-of-rise in drug concentrations and a delayed time to the maximum concentration.

We completed a Phase 2 proof-of-concept study evaluating ADS-5102 in patients with MS who have walking impairment. In the study, patients treated with ADS-5102 showed a significant improvement in walking speed as assessed by the Timed 25 Foot Walk (T25FW) test and an improvement in the Timed Up and Go (TUG). In addition, ADS-5102 was generally well tolerated.

Based on the positive Phase 2 data, we’ve initiated the first Phase 3 study in MS patients with walking impairment in April. Our Phase 3 program is planned to consist of two Phase 3 studies, a pivotal efficacy and safety study, and an open label safety study. We are also completing non-clinical studies to support the approval in this multiple sclerosis population. If the first pivotal Phase 3 study is successful, we intend to meet with the FDA to confirm the filing requirements for this supplemental NDA.

ADS-5102 References: 1. Sutliff, M. H. Contribution of impaired mobility to patient burden in multiple sclerosis. Curr Med Res Opin; 2010 26(1): 109-119. 2. Kurtzke, J. F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS) and Form. Neurology; 1983 33(11):1444-1452. 3. Cohen, R. A., H. R. Kessler, et al. The Extended Disability Status Scale (EDSS) as a predictor of impairments of functional activities of daily living in multiple sclerosis. J Neurol Sci; 1993 115(2):132-135. 4. Hobart, J. C., A. Riazi, et al. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology; 2003 60(1):31-36. 5. Rossi, S., V. Studer, et al. Opposite roles of NMDA receptors in relapsing and primary progressive multiple sclerosis. PLoS One; 2013 8(6):e67357. 6. Cohen, R.A., and M. Fisher. Amantadine Treatment of Fatigue Associated with Multiple Sclerosis. Arch Neurol; 1989; 46:676-680. 7. Socie, M.J., et. al. Gait variability and disability in multiple sclerosis. Gait & Posture; 2013 38:1-55.

ADS-4101 (lacosamide)
modified-release capsules

Epilepsy: Partial-onset Seizures

Epilepsy affects an estimated 2.2 million Americans, of which 60% have partial onset seizures.1,2 Monotherapy treatment of partial seizures is effective in approximately 60% of patients, leaving the remainder of patients to require adjunctive treatment with one or more additional anticonvulsant therapies.3,4 There are limited data on the temporal distribution of seizures over the 24-hour day, however, published studies suggest that seizures occur in a diurnal pattern, characterized by a peak between 8 AM and 4 PM, and lowest between midnight and 8 AM.5 Thus, by matching the timing pattern of seizures to the concentration of the anti-epileptic drug, with a higher drug concentration during the day and lower drug concentration during the night, may enable improved seizure control.

Clinical studies of lacosamide, an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB, Inc. as VIMPAT® (lacosamide), have reported dose limitations due to dizziness immediately following administration.6 We hypothesized the dizziness associated with higher doses might be in part attributed to the rapid initial rate-of-rise in drug concentration. Adamas scientists confirmed this time-dependent effect through in vivo modeling and preclinical experiments, showing that tolerability was dependent on rate-of-rise of drug concentration and not on maximum concentrations (Cmax).

ADS-4101, a high-dose lacosamide investigational agent taken once-daily at bedtime, was designed to have a slow initial rate-of-rise in lacosamide concentrations, to potentially improve the adverse event profile. This slow initial rise may enable a higher once-daily bedtime dose, potentially resulting in a higher daytime concentration than VIMPAT.

We have completed two Phase 1 studies of ADS-4101 in healthy volunteers. The Phase 1a study showed that a single 400 mg dose of ADS-4101 was better tolerated compared to the equivalent dose of VIMPAT immediate release tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced rate of initial rise and delayed time to maximum drug concentration appropriate for bedtime dosing. The recently completed and reported results of a multi-dose Phase 1b study demonstrated that a 600mg dose of ADS-4101, taken once-nightly, provided a 1.5 to 2.5-fold increase in average lacosamide concentrations throughout the day compared to the maximum approved daily dose of 400 mg, taken as 200 mg twice-daily (BID), of VIMPAT immediate release tablets in healthy volunteers, with comparable tolerability.

ADS-4101 References: 1. Hirtz, D., Thurman, DJ., et al. How common are the “common” neurological disorders? Neurology; 2007 68:326-337. 2. Tellez-Zenteno, JF., Ronquillo LH., et al. Discontinuation of antiepileptic drugs after successful epilepsy surgery. Epilepsy Res; 2012 102(1-2):23-33. 3. Kwan, P. B., M. J. Early identification of refractory epilepsy. N Engl J Med; 2000 42(5):314-319. 4. Brodie, M. J., S. J. Barry, et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology; 2012 78(20):1548-1554. 5. Hofstra, W. A., B. E. Grootemarsink, et al. Temporal distribution of clinical seizures over the 24-h day: a retrospective observational study in a tertiary epilepsy clinic. Epilepsia; 2009 50(9):2019-2026. 6. Horstmann, R., R. Bonn, et al. Basic Clinical Pharmacologic Investigations of the New Antiepileptic Drug SPM 927. Epilepsia; 2002 43(S7).

Clinical Program Director

The Clinical Program Director plays a lead role in developing Adamas clinical operations team and infrastructure for a given project(s). (S)He will provide strategic input and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality and risk mitigation. This position is based in Emeryville, CA and reports to the VP, Clinical Operations.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Counsel / Senior Counsel, Healthcare Law

The Counsel / Senior Counsel, Healthcare Law, will support legal matters related to the strategy and execution of commercial, medical, and clinical activities. This position reports to the Assistant General Counsel and is expected to work closely with other members of the legal and compliance group, as well as executive, commercial, medical, regulatory, and clinical teams.  This position is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Desktop Engineer, Information Technology

The Desktop Engineer is responsible for developing, deploying, and managing end user’s systems security, automation, software deployment, software patch remediation and device management in addition to providing escalated helpdesk support to internal users. This position will be tasked with creating functional deliverables, such as; testing plans/scripts, creating training plans and on-boarding manuals, identifying gaps, and providing solutions to IT related matters. This position reports to the Senior Manager, IT Operations and is located in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director / Sr. Director, Talent Acquisition and Employee Engagement

The Director / Sr. Director, Talent Acquisition and Employee Engagement, is a highly visible position accountable for leading the talent acquisition, OD/learning and development and employee relations functions in a fast-paced, entrepreneurial organization. The Director will partner with business leaders and hiring managers to support business strategies and educate teams on process and requirements. The role reports directly to the SVP, HR and is based in Emeryville, CA.

Responsibilities:

Develops and executes talent acquisition, OD/learning and development and employee relations strategies and tactics.

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Commercial Operations

The Director, Commercial Operations partners with the Commercial Organization to drive and measure performance by providing subject matter expertise, leadership and insights with a primary focus on Reporting, Incentive Compensation, and CRM/DW/MDM. This position reports to the Vice President, Commercial Operations and is based in Emeryville, CA.

Responsibilities:

Qualifications:

Competencies:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Development Regulatory Affairs

The Director, Development Regulatory Affairs ensures that regulatory expertise is provided for all investigational drug development programs to enable product registration. The incumbent will be an effective collaborator with the research, clinical research, clinical operations, pharmaceutical development, and quality departments. This position reports to the Vice President, Regulatory Affairs and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Drug Product Manufacturing

The Director, Drug Product Manufacturing will be responsible for managing manufacturing activities at contract manufacturers (CMOs) to support global markets. The position involves working with Pharmaceutical Development to transfer manufacturing processes, production scheduling, process troubleshooting and overseeing manufacture of commercial drug product. The successful candidate will work in a collaborative internal team environment as well as with external vendors to ensure manufacturing timelines are met. The candidate must have thorough understanding of major manufacturing processes and technical understanding of equipment used in solid dosage drug products. This position will be reporting to the Vice President, Manufacturing Operations and is based in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Nonclinical and Clinical Pharmacokinetics

The candidate will reside in the Research Department and will collaborate on project teams to provide key pharmacokinetic expertise to all stages of nonclinical and clinical development. In this capacity, the candidate will contribute to the design, execution, and analysis of nonclinical and clinical studies and the analysis and interpretation of pharmacokinetic data. The successful candidate will possess the relevant background and experience in pharmacokinetics in order to effectively execute program objectives. The candidate will be based in Emeryville, CA and will report to the Vice President, Research.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Quality Assurance

The Director, Quality Assurance is responsible for all aspects quality assurance and GxP compliance. The Director, Quality Assurance will establish quality plans and policies and report to Quality Management on a regular basis on compliance activities and findings. This position will design, implement and maintain QA and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits. The Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. This position will serve as an in-house advisor on GxP compliance and report to the Vice President, Quality Assurance and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Executive Assistant to the CEO

Reporting to the Chief Executive Officer, the Executive Assistant will provide advanced administrative support to help ensure the smooth operations of the Executive Office. Specifically, the Executive Assistant will directly support the Chief Executive Officer (CEO), as well as the Chief Financial Officer (CFO). Successful candidates will be extremely well organized, excellent communicators, capable of effectively managing complex schedules, and working closely with other members of the Adamas Administrative team to coordinate senior management activities. The EA will also be the lead interface with the company Board of Directors as well as external partners, The Executive Assistant will be able to anticipate many of the needs of the team and will be proactive in the execution of those needs.  The position is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Manager, Quality Systems

Manager, Quality Systems is responsible for managing the systems related to GxP compliance. This includes the daily administration tasks of the quality systems such as tracking, indexing, evaluating through metrics, and the management of the documents and records. This person will manage and facilitate quality system implementation, standardization, and maintenance in addition to serving as the Subject Matter Expert (SME) for the use of these systems. The quality systems at Adamas are a blend of manual and electronic records which include but are not limited to: Standard Operating Procedures (SOPs), forms, specifications, master and executed batch records, deviations, CAPA’s, complaints, validation and stability protocols, training records, staff CVs, job descriptions and other relevant GXP documents This position reports to the VP, Quality Assurance and is located in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Director/ Senior Medical Director

The Medical Director / Senior Medical Director will be integrally involved in all aspects of clinical trial design and execution, including authoring of protocols, site initiation, and medical monitoring, as well as data interpretation and reporting. Position reports to Senior Vice President, Clinical Research and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Science Liaison / Sr. Medical Science Liaison (Central)

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Director, Research

The candidate will lead a team of scientists to conduct nonclinical efficacy and safety studies in support of Adamas’ neurological diseases projects. In this capacity, the candidate will develop nonclinical strategies and oversee the design, execution, analysis, and reporting of the research components of discovery and development programs. The successful candidate will possess the relevant background and experience in neuroscience, and possess appropriate leadership skills, in order to effectively execute program objectives. The candidate will be based in Emeryville, CA and will report to the Vice President, Research.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Manager / Associate Director, Pharmaceutical Development

The Senior Manager / Associate Director, Pharmaceutical Development contributes to the drug product development process by developing formulations for preclinical and clinical evaluation.  It involves working collaboratively within a multidisciplinary framework within the organization and with external contract manufacturing organizations. This position is based in Emeryville, CA and reports to the Vice President, Pharmaceutical Development.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Manager, Commercial Quality Assurance

The Senior Manager, Commercial Quality Assurance is responsible for managing quality operations at Adamas commercial service providers of drug substance, drug product, packagers and distribution centers to ensure that CSP are in compliance with applicable regulations, Quality Agreement(s), and Standard Operating Procedures (SOP’s). This position reports to the Vice President, Quality Assurance and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Vice President, Development Operations

The Senior Vice President, Development Operations is the Company’s research and development (R&D) operational expert and oversees the successful execution of all clinical and regulatory contributions to our new drug applications. The SVP will build and manage a highly functioning regulatory affairs and clinical operations departments. Ensures regulatory expertise is provided across the discovery, development, and commercial continuum. Ensures all Adamas development programs target a clearly defined goal (i.e., target product profile) and are filled with the results of well executed clinical trials within time, budget, and quality constraints. Owns the creation and implementation of all R&D dashboards. Partners with the heads of research, clinical research and medical affairs, as per guidance from the Chief Medical Officer. The incumbent reports directly to the CEO and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Vice President, Corporate Communications

The Vice President, Corporate Communications at Adamas will lead the continued development and dissemination of the Adamas brand to internal and external stakeholders. With the CEO, this person will set Adamas’ communications strategy, develop brand, positioning and core messaging, build relationships with key channels, and effectively communicate about the Company to all internal and external constituencies. This person will work closely with the entire executive leadership team to craft and deliver content. Corporate Communications will work closely with Investor Relations to shape the message for the financial audience, and have a seat on the Brand teams, to ensure compatibility between the Corporate and Product Brands.  The Vice President, Corporate Communication will also be a main contact for all media, advocacy relationships and government affairs.  This position reports directly to the CEO, and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Vice President, Medical Affairs

The Vice President, Medical Affairs is responsible for the design and implementation of all medical affairs deliverables, including, but not limited to medical information, field medical science liaison team, medical affairs related collateral development, investigator independent studies, and medical education grants. The position reports to the Chief Medical Officer and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Vice President, Regulatory Affairs

The Vice President, Regulatory Affairs oversees the regulatory affairs department. Ensures regulatory expertise is provided across the discovery, development, CMC, and commercial continuum. Must be an experienced regulatory strategist and thought partner, for both development and commercialization of pharmaceutical products. The incumbent works closely with the heads of non-clinical research pharmacology, clinical research, clinical operations, and medical affairs; is also an effective collaborator with the commercial and legal departments. The position will report to the Senior Vice President, Development and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.